IPS

GUDID 00888118122728

CASE COMPLETE, CRANIAL, W/MARKING GUIDE AND 2 CRYSTAL MODELS, COMPLEX

KLS-Martin L.P.

Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: 00888118122728
• NIH Device Record Key: 738e97d5-0016-4717-a434-037a4ad05c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IPS
• Version Model Number: 60-002-54-09
• Company DUNS: 826499238
• Company Name: KLS-Martin L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888118122728 [Primary]

FDA Product Code

• PPT: Cranial surgical planning and instrument guides

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00888118122728]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-09-20

On-Brand Devices [IPS]

• 10888118117349: 60-500-03-09
• 10888118117332: 60-500-02-09
• 10888118117325: 60-500-01-09
• 10888118097825: 60-002-10-09
• 10888118097818: 60-002-09-09
• 10888118097801: 60-002-08-09
• 10888118097795: 60-002-07-09
• 10888118097788: 60-002-06-09
• 10888118097771: 60-002-05-09
• 00888118117366: CUTTING GUIDE, RECON, STANDARD, 00162
• 00888118117359: CUTTING GUIDE, RECON, BONE GRAFT, 00161
• 00888118115928: 60-001-52-09
• 00888118115904: 60-001-50-09
• 00888118115898: 60-001-49-09
• 00888118115843: 60-001-44-09
• 00888118115836: 60-001-43-09
• 00888118115829: 60-001-42-09
• 00888118115812: 60-001-41-09
• 00888118115799: 60-001-12-09
• 00888118115782: 60-001-11-09
• 00888118115775: 60-001-10-09
• 00888118115768: 60-001-09-09
• 00888118115751: 60-001-08-09
• 00888118115744: 60-001-07-09
• 00888118115737: 60-001-06-09
• 00888118115720: 60-001-05-09
• 00888118115713: 60-001-04-09
• 00888118115706: 60-001-03-09
• 00888118115690: 60-001-02-09
• 00888118115683: 60-001-01-09
• 00888118115676: 60-001-00-09
• 00888118121776: 60-500-21-09
• 00888118120793: IMPLANT, MIDFACE, 00198, TI-6AL-4V
• 00888118120786: IMPLANT, MANDIBLE, CRIB MESH, 00195, 2.0-3.2 MM SCREW, TI-6AL-4V
• 00888118120595: IMPLANT, MIDFACE, 00194, PEEK
• 00888118120090: CUTTING GUIDE, RECON, CUTTING SLOT
• 00888118120007: MARKING GUIDE, RECON/DIST, EXTRA, LARGE
• 00888118119995: MARKING GUIDE, RECON/DIST, EXTRA, SMALL
• 00888118119988: MARKING GUIDE, W/PLANNING, RECON/DIST
• 00888118119971: CUTTING GUIDE, RECON, EXTRA, LARGE
• 00888118119964: CUTTING GUIDE, RECON, EXTRA, SMALL
• 00888118119957: CUTTING GUIDE, W/PLANNING, RECON
• 00888118119940: MARKING GUIDE, ORTHOG/MAND, 00197
• 00888118119933: MARKING GUIDE, ORTHOG/MAX, 00196
• 00888118119926: CUTTING GUIDE, ORTHOG, COMPLEX, 00163
• 00888118119919: CUTTING GUIDE, W/PLANNING, RECON, COMPLEX, 00160
• 00888118119902: MARKING GUIDE, RECON, BONE GRAFT, 00012
• 00888118106353: PEEK, LARGE, PEEK
• 00888118106018: IPS, PEEK, PEEK
• 00888118105653: PEEK, PEEK